FDA.reportPublic FDA data

MAUDE MDR 9578627

MDR report key
9578627
Report number
3006630150-2020-00034
Event key
0
Event type
3
Date of event
2019-12-13
Date received
2020-01-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
TALAR TAHMASIAN
Address
25155 RYE CANYON LOOP VALENCIA CA 91355 US
Phone
661-661-6619
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROSTHESIS, SPINOUS PROCESS SPACER/PLATEVERTIFLEX INC.NQOR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-1001. R

Event Narratives#

D

Patient 1

A REPORT WAS RECEIVED THAT THE PATIENT'S INITIAL SPACER HAD MOVED LATERALLY FROM THE INITIAL POSITION AND WAS NO LONGER PROVIDED RELIEF. THE PHYSICIAN REMOVED THE SPACER AND REPLACED IT WITH A LARGER SPACER. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.